Diabetic Retinopathy Clinical Trial
Official title:
Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Ocular Diseases
Verified date | December 4, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will identify genes that are associated with inflammation or degeneration of the
retina (membrane lining the back of the eye that relays vision signals to the brain). It is
thought that many retinal conditions are due to an altered immune system and are based on how
the person s genes function and communicate.
People 4 years of age or older who have a retinal condition such as uveitis, age-related
macular degeneration or diabetic retinopathy may be eligible for this study. Healthy
volunteers and healthy people who have a family member with one of these conditions are also
eligible. Patients with inherited retinal degeneration are excluded.
Participants undergo the following tests and procedures:
- Eye examination to assess visual acuity (eye chart test) and eye pressure, and to
examine the pupils, lenses, retina and eye movements. Photographs of the inside of the
eye may also be taken. The pupils are dilated with drops for this examination.
- Blood draw for genetic testing.
Participants may also undergo one or more of the following tests:
- Optical coherence tomography. This is a type of photograph of the back of the eye to
measure thickness of the retina.
- Fluorescein angiography and indocyanine green angiography. Pictures of the eye s blood
vessels are taken using either a fluorescein or indocyanine green dye. The dye is
injected into a vein in an arm and travels to the blood vessels in the eyes. A camera
takes pictures of the dye as it flows through the blood vessels.
- Electroretinogram (ERG) to measure retinal function. The patient sits in a dark room for
30 minutes with his or her eyes patched. Then, a small metal disk electrode is taped to
the forehead, the eye patches are removed, the surface of the eye is numbed with eye
drops, and contact lenses are placed on the eyes. The patient then watches flashing
lights. The contact lenses sense small electrical signals generated by the retina when
the light flashes....
Status | Completed |
Enrollment | 609 |
Est. completion date | December 4, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years and older |
Eligibility |
- INCLUSION CRITERIA: Participants with the following will be recruited: - Individuals or family members of individuals with immune mediated retinal disorders, including uveitis, age related macular degeneration, and diabetic retinopathy. - Adults must be capable of providing their own consent. - All participants must be able to cooperate with study examination and phlebotomy. - Children must be older than 4 years of age. EXCLUSION CRITERIA: - Individuals with diseases, infections, or trauma that mimic immune medicated retinal disorders. - Children requiring sedation for study procedures. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Becker KG, Simon RM, Bailey-Wilson JE, Freidlin B, Biddison WE, McFarland HF, Trent JM. Clustering of non-major histocompatibility complex susceptibility candidate loci in human autoimmune diseases. Proc Natl Acad Sci U S A. 1998 Aug 18;95(17):9979-84. — View Citation
Carrel L, Willard HF. X-inactivation profile reveals extensive variability in X-linked gene expression in females. Nature. 2005 Mar 17;434(7031):400-4. — View Citation
Richardson B. Primer: epigenetics of autoimmunity. Nat Clin Pract Rheumatol. 2007 Sep;3(9):521-7. Review. — View Citation
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